CICL offers independent third-party analysis and interpretation of echocardiographic images for industry-sponsored and investigator-led clinical trials.


Our experience extends across FIH, EFS, pivotal, post-marketing surveillance and IDE trials

Cardiac imaging core lab (CICL) offers independent third-party analysis and interpretation of echocardiographic images for industry-sponsored and investigator-led clinical trials

CICL offers the following modalities:

  • 2D and Doppler echocardiography
  • 3D structural and functional analyses of the mitral valve, tricuspid valve, left ventricle and right ventricle
  • Speckle tracking strain

Services

Quality image analysis


  • Two-step verification: All images analyzed by our sonographers are verified and finalized by a qualified physician.
  • Rigorous quality check of data-entry: All data entered into the EDC is checked by a second CICL staff member to ensure they match with that entered into the PACS system and are error-free.
  • Control for inter/intra-operator variability: We periodically assess measurements by our sonographers, and retrain them if necessary, to mitigate variability in measurements that impact study data.
  • Turnaround time: Complete analysis of screening cases in 24-36 hours, and follow-up images in 72 hours, on average.
  • Capacity: Standard support analysis of several thousand images per year with ability to expand staff as needed.
  • Compliance with industry regulations: FDA Regulations, FDA Guidance for Industry (Computerized systems and Electronic Source Data in Clinical Investigations) and ICH-GCP E6, ISO 14155 (Clinical Investigation of Medical Devices for Human Subjects).

Expertise

Medical Director Paul Grayburn, MD brings more than 40 years of echocardiography experience in the valvular heart disease to the Core Lab. The program's world-renowned team of cardiac sonographers embody years of extensive experience in the structural and valvular heart disease field, with several high-impact scientific publications.

The program’s effective team of cardiac sonographers embody years of extensive experience in the structural and valvular heart disease field, with several high-impact scientific publications.

Areas of expertise

  • Mitral Regurgitation: Percutaneous and surgical treatment strategies
  • Tricuspid Regurgitation: Percutaneous and surgical treatment strategies
  • Aortic Stenosis: Percutaneous and surgical treatment strategies
  • Heart Failure: Medical and Device Treatment
  • Aortic Disease: Acute Dissection

Clinical breadth and depth of our sonographers

  • Our cohesive group of experienced sonographers have extensive echocardiography practice and undergo formal training to standardize techniques of image analysis.
  • CICL Sonographers are long-term members of professional societies such as American Society of Echocardiography (ASE) and American Society of Radiologic Technology (ASRT). They are also trained on human subjects research practices such as GCP, HSP and handling of electronic data.

Assured consistent quality

We take special measures to remove bias and variability due to subjective interpretation of images by our sonographers.


Time-zone coverage

Our team is distributed in the US, Germany and Italy, allowing us to provide round-the-clock support to our study-sponsors.


Track record

We are actively engaged in several large-scale trials at the highest standards of service.

Leadership and staff

Leadership


As part of Baylor Scott & White The Heart Hospital – Plano, our Core Lab is guided by an expert senior leadership team of world-renowned cardiac surgeons and cardiologists with extensive expertise in directing image-related research studies and leading numerous national and international trials.


Michael Mack

Michael Mack, MD

michael-dimaio.jpg

J. Michael DiMaio, MD

Robert L Smith

Robert L. Smith, MD



William Halsell Ryan

William Halsell Ryan, MD

Molly Szerlip

Molly Szerlip, MD

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Zuyue Wang, MD

Publications

Contact us

Cardiac Imaging Core Lab (CICL)
Baylor Scott & White Research Institute
1100 Allied Drive, Suite 5-504
Plano, TX 75093

Paul A. Grayburn, MD, FACC, FASE, Medical Director
Phone: 469.814.4817
Email: Paul.Grayburn@BSWHealth.org

Anna Sannino, MD, PhD, FASE, Scientific Director
Phone: 469.867.8924
Email: Anna.Sannino@BSWHealth.org

Preethi Ravindranathan, MS, Project Manager
Phone: 469.814.4721
Email: Preethi.Ravindranathan@BSWHealth.org

Baylor Scott & White The Heart Hospital - Plano
1100 Allied Drive
Plano, TX 75093

More about research at Baylor Scott & White

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